Repetitive Transcranial Magnetic Stimulation (rTMS) in Post-Traumatic Stress Disorder: Study Protocol of a Nationwide Randomized Controlled Clinical Trial of Neuro-Enhanced Psychotherapy "TraumaStim"

Florian Ferreri; Stephane Mouchabac; Vincent Sylvestre; Bruno Millet; Wissam El Hage; Vladimir Adrien; Alexis Bourla

doi:10.3390/brainsci13091274

Repetitive Transcranial Magnetic Stimulation (rTMS) in Post-Traumatic Stress Disorder: Study Protocol of a Nationwide Randomized Controlled Clinical Trial of Neuro-Enhanced Psychotherapy "TraumaStim"

Brain Sci. 2023 Aug 31;13(9):1274. doi: 10.3390/brainsci13091274.

Authors

Florian Ferreri^{1

2}, Stephane Mouchabac^{1

2}, Vincent Sylvestre¹, Bruno Millet^{2

3}, Wissam El Hage⁴, Vladimir Adrien^{1

2}, Alexis Bourla^{1

2

5

6}

Affiliations

¹ Department of Psychiatry, Hôpital Saint-Antoine, Sorbonne Université, AP-HP, 75012 Paris, France.
² ICRIN-Psychiatry (Infrastructure of Clinical Research in Neurosciences-Psychiatry), Brain Institute (ICM), Sorbonne Université, INSERM, CNRS, 75013 Paris, France.
³ Service de Psychiatrie Adulte de la Pitié-Salpêtrière, Sorbonne Université, AP-HP, 75013 Paris, France.
⁴ Centre Régional de Psychotraumatologie CVL, CHRU de Tours, UMR 1253, iBrain, Université de Tours, INSERM, 37000 Tours, France.
⁵ Clariane, Medical Strategy and Innovation Department, 75008 Paris, France.
⁶ NeuroStim Psychiatry Practice, 75005 Paris, France.

Abstract

The use of high-frequency Transcranial Magnetic Stimulation (HF-rTMS) of the right dorsolateral prefrontal cortex (DLPFC) in treating Post-traumatic Stress Disorder (PTSD) is currently regarded as a level B intervention (probable effectiveness). HF-rTMS has attracted interest as a neuromodulation therapeutic method for PTSD. Prolonged exposure and reactivation therapy are also regarded as first-line treatments for PTSD. Randomized controlled clinical studies examining the effectiveness of several HF-rTMS sessions coupled with psychotherapy have not yet been completed. In total, 102 patients with refractory PTSD will be randomly assigned (1:1) to reactivation therapy, in addition to either active HF-rTMS (20 Hz) or sham HF-rTMS, for 12 sessions in a nationwide, multicenter, double-blind controlled trial. The impact on PTSD symptoms and neurocognitive functioning will be assessed. The primary outcome is the PTSD severity score measured based on the Clinician-Administered PTSD Scale (CAPS-5) at one month. If this additional therapy is successful, it may strengthen the case for regulatory authorities to approve this additional technique of treating PTSD. Additionally, it expands the field of neurostimulation-assisted psychotherapy.

Keywords: neurostimulation-assisted psychotherapy; post-traumatic stress disorder; transcranial magnetic stimulation.

Grants and funding

This research is financed by the Hospital Clinical Research Program PHRC -19-0413, 750712184, AP-HP. The funding body did not play any role in the design of the study, nor did it play a role in data collection, analysis, interpretation of data, or writing of manuscripts.